Theralink Begins Testing New Biomarker Assay for Breast Cancer Tumors



Theralink Biomarker Assay

Theralink Technologies announced that it has begun testing its new profiling biomarker assay — a test that could potentially provide oncologists with key information about a patient’s specific tumor — in people with breast cancer.

“The Theralink assay for breast cancer may reveal therapeutic options for oncologists and in turn, may provide better outcomes for breast cancer patients,” Mick Ruxin, MD, president and CEO of Theralink, said in a press release.

The new test uses Reverse Phase Protein Array (RPPA) technology to measure the abundance and activation of hundreds of biomarker proteins and their signaling pathways directly from a microscopic tumor sample (biopsy).

When these proteins are activated, they may serve as active drug targets for most FDA-approved and investigational therapies for cancer.

By measuring the levels and activity of dozens of drug targets at once, this highly sensitive platform can provide important information about the patient’s specific tumor, paving the way for molecular targeted therapies, the company said.

Importantly, this kind of information is currently missed by existing genomic and transcriptomic assays — those that give information on which genes are being actively transcribed into RNA and how much so. Of note, RNA typically contains information to produce proteins.

The new assay initially will be used for several types of breast cancer, including metastatic, inflammatory, and late-stage triple-negative cancers. Late-stage hormone epidermal growth factor receptor 2 (HER2) positive, and late-stage estrogen receptor (ER) positive HER2 negative (ER+/HER2-) breast cancers also will be tested using Theralink, the company said.

However, the company noted, the test also can be expanded for most solid tumors, including but not limited to non-small cell lung, colorectal and pancreatic cancer.

“Theralink’s testing is initially for breast cancer, but we plan to offer the Theralink assay for numerous other cancer types in the near future,” Ruxin said.

The molecular findings collected by Theralink’s assay have the potential to help physicians improve treatment decisions by determining the ideal prescribed medication for patients based on the unique molecular characteristics of their tumor.

This new source of information also can help improve treatment outcomes and reduce side effects by foregoing ineffective therapies and correctly classifying likely treatment responders and non-responders.

“With our unique molecular profiling assay, that goes beyond a genomics-only approach, physicians throughout the country … will have access to potentially critically missing and actionable information to help them make time-sensitive treatment decisions for their patients,” Ruxin said.

The company is currently accepting patients’ tumor samples from states across the U.S., with the exception of New York and California, which await Clinical Laboratory Improvement Amendments (CLIA) certification.

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